Apparatus and method for cosmetic treatment of human mucosal tissue

ABSTRACT

A device for providing fractional treatment of a body orifice includes a source of fractionated energy and a source of electrical muscle (EMS) energy. A programmed controller controls the application of fractionated and/or EMS energy. A probe is inserted by its distal end into the body orifice. The source of fractionated energy is positioned for transmitting fractionated energy from the source of fractionated energy through the probe to tissue in the vicinity around the body orifice; and, the source of EMS is positioned for transmitting EMS energy from the source of EMS energy through the probe to tissue in the vicinity around the body orifice. The programmed controller is configured to control the activation of fractionated energy and EMS energy one of simultaneously or sequentially.

RELATED APPLICATIONS

The present application is related to, claims priority to and is acontinuation in part of U.S. application Ser. No. 13/510,062, filed May16, 2012, which is a 371 national phase application of PCT/IL10/00947,filed Nov. 16, 2010, which claims priority to U.S. ProvisionalApplication Ser. No. 61/261,381, filed Nov. 16, 2009, the entirety ofwhich are hereby incorporated by reference.

FIELD OF THE INVENTION

The present invention relates to the use of one or more treatmentmodalities in the cosmetic treatment of human mucosal tissue to provide,among other things, vaginal and anal tightening and urinary incontinencetreatment.

BACKGROUND OF THE INVENTION

Vaginal Relaxation Syndrome (VRS) commonly called “loose vagina” is aquite common medical condition described as a loss of the optimalvaginal structure and is usually associated with vaginal child deliveryand natural aging.

Multiple pregnancies and deliveries contribute to a worsening of the VSRcondition, as well as the beginning of menopause, which causes a declinein hormone levels and vaginal atrophy.

Most women and their husbands or partners refer to VSR as “loosevagina”, complaining of a loss of vaginal tightness, which is directlyrelated to the reduction of friction during intercourse and thus to adecrease or loss of sexual gratification.

There is a large spectrum of various VRS treatment options on the marketranging from behavioral (Kegel exercises) through pharmacologicaltherapies (hormonal, tightening creams and sprays) to variousmore-or-less invasive surgical procedures.

While behavioral and pharmacological therapies are noninvasive and safe,they have limited efficacy.

On the other hand, various surgical procedures promise a much betterfinal result at the price of higher associated risks.

Surgical procedures require the cutting and rearrangement of vaginal andperipheral tissue in order to reduce the size of the vaginal canal.

Operating on or near sensitive vaginal tissue is inherently risky andcan cause scarring, nerve damage and decreased sensation. Furthermore,patients require an extended recovery period.

The most popular among the surgical procedures are those performed withlasers, where the laser is used instead of scalpel.

Thus there is a clear need for efficient noninvasive solutions forvaginal rejuvenation.

Numerous techniques have been described for tissue rejuvenation mostlyfor skin treatment. For example, U.S. Pat. No. 6,387,089 describes aprocedure referred to as photo rejuvenation, wherein pulsed light isused for heating and shrinking the collagen and thereby restoring theelasticity of the skin. Since collagen is located in the dermis, lasersthat target collagen must penetrate through the epidermis and throughthe dermal epidermal junction. Due to Bier's Law of absorption, thelaser beam is typically most intense at the surface of the skin. Thisresults in unacceptable heating of the upper layers of the skin. Variousapproaches have been described to cool the upper layers of the skinwhile maintaining the layers underneath at the desired temperature. Oneapproach is to spray a cryogen material on the surface so that thesurface remains cool while the underlying layers (and hence collagen)are heated. Such an approach is described in U.S. Pat. No. 6,514,244.Another approach, described in U.S. Pat. No. 6,387,089, is the use of acooled transparent substance, such as ice, gel or a crystal that is incontact with the surface of the skin. The transparent nature of thecoolant allows the laser beam to penetrate the different skin layerswhile maintaining an acceptable temperature level on the surface of theskin.

An objective of non-ablative photo-rejuvenation is to induce a thermalwound repair response in the papillary and upper reticular dermalcompartments (approximately 100-400 micro-meter below the surface of theskin) while sparing the epidermal compartment.

To overcome some of the problems associated with the undesired heatingof the upper layers of the skin (epidermal and dermal) described above,U.S. Pat. No. 6,311,090 describes using RF energy and an arrangementcomprising RF electrodes that rest on the surface of the skin. A reversethermal gradient is created that apparently does not substantiallyaffect melanocytes and other epithelial cells. However, even suchnoninvasive methods have the significant limitation in that energycannot be effectively focused in a specific region of interest forexample the dermis.

Other approaches have been described to heat the dermis without heatingmore superficial layers. These involve using electrically conductiveneedles that penetrate the surface of the skin into the tissue andprovide heating. U.S. Pat. Nos. 6,277,116 and 6,920,883 describe suchsystems. Unfortunately, such an approach results in widespread heatingof the subcutaneous layer and potentially melting the fat in thesubcutaneous layer. This leads to undesired scarring of the tissue.

One approach that has been described to limit the general, uniformheating of the tissue is fractional treatment of the tissue, asdescribed in U.S. Patent Application publication No. 2005/0049582. Thisapplication describes the use of laser energy to create treatment zonesof desired shapes in the skin, where untreated, healthy tissue liesbetween the regions of treated tissue. This enables the untreated tissueto undergo a healing and recovery process.

As opposed to traditional laser resurfacing, which treats the wholesurface of the target tissue, fractional laser skin resurfacing usesfractional Photothermolysis. It targets tissue with a pattern ofdispersed spots. This results in a pattern of microscopic zones oftissue coagulation that heal over several weeks while the skin retainsnormal appearance. Rather than creating a global tissue effect at thesurface of the target tissue, or in the dermis alone, this methodcreates injury in a small fraction of the skin treated, coagulatingmultiple columns of tissue, generally 70-100 micron in diameter,extending through the epidermis and deep into the dermis reaching up togenerally 1 mm depth. These laser columns create micro thermal zones oftissue coagulation which is surrounded by healthy tissue. The healthytissue provides a generous reservoir of stem cells and melanocytes inthe papillary dermis that are spared from wounding and accelerate thehealing process. The small size of the wounds and the short migratorypaths for keratinocytes from the spared tissue result in rapidre-epitheliazation and fast epidermal repair. Zones of collagendenaturation in the dermis cause upregulation of the inflammatorycascade, which leads to collagen remodeling to depths of generally400-700 microns resulting in skin tightening. The fact that patients donot have open wounds leads to minimal downtime. Fractional laserresurfacing is therefore a non-ablative procedure. It offers improvedskin texture, tone, pigmentation, fine lines and skin tighteningFractional resurfacing requires a series of 3-5 treatments as opposed toablative lasers that require a single treatment.

Fractional vaginal rejuvenation systems exist in the market using CO2 orEr:YAG lasers. These include, for example, IntimaLase by Fotona—aminimally-invasive, non-ablative Er:YAG laser vaginal tighteningprocedure utilizing photothermal laser-mucosa tissue interaction.Another device is FemiLift by Alma Laser. This is a noninvasive LaserVaginal Tightening device using CO2 laser by thermal heating of thevaginal tissue inner layers inducing collagen and elastin contractionand regeneration of the proteins over time.

Disadvantages of such known fractional laser resurfacing systemsinclude: they are cumbersome and expensive. As well, in order to achievedramatic results heating of the tissue reaches the temperature in thenecrotic zone which is around 70° C., and the tissue, whether it is madeup primarily of cells, keratinocytes and their derivatives or collagen,is necrosed or denatured, respectively. Temperatures in the tissue above100° C. may cause steam to form in the tissue, which may causedisruptive effects. Such temperatures may result in undesirable sideeffects such as pain, erythema, swelling, occasional scarring, extendedhealing times and infection.

Thus there is an unmet need for a simple, inexpensive fractionaltreatment of the vagina that causes tissue injury and triggers tissuehealing processes but without the risks and complications caused bytissue heating that creates denaturation and coagulation of tissue.While the present invention may be administered within the confines of aphysician's or other operator's office environment, it is ofsufficiently simple operation that it may be used in the privacy of theuser's home. For example, the present invention may have a switch orother device so that the EMS function may be separable from the RFfunction so that a user can activate the EMS portion of the presentapparatus without activating the RF function for training and/or vaginaltightening purposes.

SUMMARY OF THE INVENTION

In an aspect, a device which provides fractional treatment of a bodyorifice includes a source of fractionated energy; a source of electricalmuscle (EMS) energy; a programmed controller to control the applicationof fractionated and/or EMS energy; a probe for insertion of its distalend into the body orifice. The source of fractionated energy ispositioned for transmitting fractionated energy from the source offractionated energy through the probe to tissue in the vicinity aroundthe body orifice; and, the source of EMS is positioned for transmittingEMS energy from the source of EMS energy through the probe to tissue inthe vicinity around the body orifice; the programmed controller isconfigured to control the activation of fractionated energy and EMSenergy one of simultaneously or sequentially.

In another aspect, the body orifice may be selected from one of: avaginal cavity; an anal cavity, the oral cavity or the aural cavity, andthe treatment provides one of vaginal or anal tightening.

In a further aspect, the fractionated energy is radio frequency (RF)energy or Ultrasound (US) energy or it may be light energy.

In yet another aspect, the controller may be configured to activate theEMS energy first, followed by activation of the RF energy, whereby thetissue in the vicinity of the body orifice is first drawn into contactwith the probe, followed by activation of RF energy. The controller mayactivate the application of EMS energy and then RF energy a selectednumber of times.

In a further aspect, the source of fractionated energy may includeelectrodes mounted on an outer surface of the probe and may be mountedin the form of one or more spirals along the other surface of the probe.The device may be for home use.

In yet another aspect, a method is providing for the fractionaltreatment of a body orifice and includes: transmitting fractionatedenergy from a source of fractionated energy through a probe inserted inthe body orifice to tissue in the vicinity around the body orifice; and,transmitting EMS energy from a source of EMS energy through the probe totissue in the vicinity around the body orifice.

In yet a further aspect, a programmed controller is configured tocontrol the transmitting of the one or more of fractionated and EMSenergy one of simultaneously or sequentially. The controller mayactivate the EMS energy first, followed by activation of the RF energy,whereby the tissue in the vicinity of the body orifice is first drawninto contact with the probe, followed by activation of RF energy. Thecontroller may activate the application of EMS energy and then RF energya selected number of times. The method may be practiced in one of anoffice or a home use.

In another aspect, the programmed controller may be configured tocontrol the activation of fractionated energy and/or the EMS energy. TheEMS energy may be activated and the fractionated energy source notactivated for purposes of tightening the body orifice, including vaginalor anal tightening.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates an overall schematic diagram of the system of thepresent invention.

FIGS. 2A and 2B illustrate a prior art probe and a probe of the presentinvention which may be utilized in connection with the system of thepresent invention.

FIGS. 2C through 2D illustrate a holder/mounter system forholding/mounting the probe of the present invention in situ.

FIG. 3 graphically illustrates the operation of the system of thepresent invention in the provision of RF and EMS energy.

DETAILED DESCRIPTION OF THE PRESENT INVENTION

One aspect of the present invention is providing a system and method oftreatment for vaginal tightening. The system, shown in FIG. 1 asreference numeral 10, includes a vaginal probe 12 which can be insertedinto the vagina and is configured to provide a combination of two typesof electrical signals to the vagina wall (not shown). The system 10 alsoincludes a power supply unit 14, a programmable controller 16 with agraphic user interface (GUI) 18. Connected to the controller are anelectrical muscle stimulation (EMS) unit 20 and a radio frequency (RF)unit 22, both of which may be selectively actuated to provide theirrespective energy inputs to the probe 12 under the control of thecontroller 16. In addition, pressure sensor 24 and temperature sensor 26may be provided to provide feedback from the probe 12 before and/orduring and/or after either one or both of the EMS unit and/or the RFunit are activated under control of the controller 16. The feedback mayinclude, by way of example only, as a measurement of the efficiency ofthe treatment in terms of time and extent of treatment. A firstelectrical signal applied is, as mentioned above, an electrical musclestimulation signal (EMS) which is purposed and designed when activatedto contract the vaginal smooth muscle around a vaginal probe 12. Asecond electrical signal is, again as mentioned above, a radio frequency(RF) signal which is purposed and designed when activated under controlof the controller to irradiate the vaginal tissue. U.S. application Ser.No. 13/510,062, which is incorporated herein by reference to thisapplication, further describes possible combinations for providing thesignals to a target tissue.

Referring now to FIG. 3, a sequence of EMS pulses followed by a RF pulseis shown. The EMS pulse serves to contract the vagina around the vaginalprobe to create a proper electrical coupling between the inner vaginaltissue and the electrodes. In addition, the pressure sensor 24 may beincorporated on the vaginal probe to measure to feedback for thepressure created by the vagina on the probe 12. The amount of pressuresensed may provide an indication of adequate or inadequate coupling ofelectrodes. The EMS pulses applied activate the muscle and flatten themucosal tissue such that the muscle are closer to the surface of theelectrodes. The controller may be disabled from activating the RF unit22 until a selected pressure reading is detected, for example.Alternatively, tissue impedance measurement by the treating electrodesby a set of dedicated electrodes may also be used, as known to thoseskilled in the art, to provide a feedback for the tissue-electrodecoupling. Furthermore, the temperature sensor 26 may provide temperaturereadings at the probe/vagina wall interface to make sure excessiveheating does not occur. Excessive heating of the vagina tissue may causethe controller to stop activation of the EMS and/or RF units.

Back to the pulse sequence in FIG. 3, a treatment RF pulse is initiatedafter the EMS signal. The EMS signals may be relatively short and may bein the range of 50-350 microsec. This signal may be repeated in afrequency of about 5-25 Hz. The temperature sensor 26 may feedback tothe controller 16 which is configured to control the RF pulse width.

RF may be bipolar or monopolar. In a monopolar configuration, anexternal electrode on the pubis or lower back may be used. EMS signalsmay use a dedicated electrode or the same electrodes used for the RFunit. In such a case, a diode bridge known to those skilled in the artmay be provided to “cut” the AC RF signals to produce an effective DCsignal in the range of 1 to 30 milliseconds. This configuration makesthe whole system much simpler and easier to implement as a home-usedevice. The DC EMS signal may cause the muscle to be smoothed out whichin turn may induce contraction.

According to one aspect of the invention, the system is configured toswitch between EMS and RF signals. An EMS signal followed by a RFtreatment signal may create thermal damage to the adjacent vaginaltissue and cause its tightening According to another embodiment of thepresent invention, RF only or EMS only signal may be used in order toheat or exercise the vagina respectively. According to yet anotherembodiment of the present invention, the order of the application of RFand EMS pulses may be in any order or sequence desired to achievedesirable treatment results.

The vagina is a hollow organ and is comprised of a smooth muscle. Smoothmuscles are characterized by high elasticity which gives them theability to stretch while still maintaining strong contractability.Smooth muscle cell cytoplasm is rich with myosin and actin moleculeswhich provide a smooth muscle cell the ability to contract. Tensilestructure between smooth muscle cells contains actin filaments ofcontractile units which are attached to dense bodies creating a networkof contracting fibers. This network is neither in a parallel lineorientation across nor along the vagina smooth muscle, rather in a morediagonal orientation. As a result, smooth muscle tends to contract in aspirally. Therefore, the most effective way to induce a stimulation of asmooth muscle may not be by providing parallel electrodes 102 along oracross a prior art vaginal probe 100 shown in FIG. 2A which is known inthe VDR technology by NovaClinical from Italy. As shown in FIG. 2B, oneor more spiral electrodes 104 are mounted or otherwise fixed onto andalong a vaginal probe 1016. Spirally-oriented electrodes are believed tobetter suited to create an effective stimuli vector in a contactingspot, given the anatomy and arrangement of the contracting fibers in thesmooth muscle of the vagina.

Turning now to FIGS. 2C and 2D, these figures illustrate arrangements ofjackets in which the vagina probe 12 of FIG. 1 may be inserted. FIG. 2Dillustrates a probe 200 with measurement markings 202, which may beevery 5-10 mm. The probe 200 may fit inside a sleeve 204 as shown inFIG. 2C. The design of the combined unit includes insertion of thesleeve 204 into the vagina. The probe 200 may then be inserted into thesleeve and thus vagina of the patient. A portion of the sleeve 204 willremain outside of the patient's body and the doctor or other operatorcan read the degree of insertion by reading the measurement markings atposition 202. This arrangement allows the doctor or other operator toselectively and/or sequentially treat various depths into the patient'svagina.

As mentioned above, it is known to provide light-based vaginalrejuvenation treatments. However, what is not believed to be known isthe combination of EM treatment combined with EMS treatment, so that thetissue surrounding the inserted probe will be drawn into contact withthe probe in order to provide more effective and efficient treatment ofthe vaginal walls due to the close contact with the probe and thus thesource of energy.

1. A device for providing fractional treatment of a body orificecomprising: a source of fractionated energy; a source of electricalmuscle (EMS) energy; a programmed controller to control the applicationof fractionated and/or EMS energy; a probe for insertion of its distalend into the body orifice; the source of fractionated energy beingpositioned for transmitting fractionated energy from the source offractionated energy through the probe to tissue in the vicinity aroundthe body orifice; and, the source of EMS being positioned fortransmitting EMS energy from the source of EMS energy through the probeto tissue in the vicinity around the body orifice; and, wherein theprogrammed controller is configured to control the activation offractionated energy and EMS energy one of simultaneously orsequentially.
 2. The device of claim 1, wherein the body orifice isselected from one of: a vaginal cavity; an anal cavity, the oral cavityor the aural cavity.
 3. The device of claim 2, wherein the treatmentprovides one of vaginal or anal tightening.
 4. The device of claim 1,wherein the fractionated energy is radio frequency (RF) energy.
 5. Thedevice of claim 1, wherein the fractionated energy is Ultrasound (US)energy.
 6. The device of claim 1, wherein the fractionated energy islight energy.
 7. The device of claim 1, wherein the controller isconfigured to activate the EMS energy first, followed by activation ofthe RF energy, whereby the tissue in the vicinity of the body orifice isfirst drawn into contact with the probe, followed by activation of RFenergy.
 8. The device of claim 7, wherein the controller activates theapplication of EMS energy and then RF energy a selected number of times.9. The device of claim 1, wherein the source of fractionated energyincludes electrodes mounted on an outer surface of the probe.
 10. Thedevice of claim 9, wherein the electrodes are mounted in the form of oneor more spirals along the other surface of the probe.
 11. The device ofclaim 1, wherein the device is for home use.
 12. A method for providingfractional treatment of a body orifice comprising: providing a source offractionated energy and a source of electrical muscle (EMS) energy;providing a programmed controller to control the application offractionated and/or EMS energy; providing a probe for insertion of itsdistal end into the body orifice; the steps including: configuring theprogrammed controller to control the activation of fractionated energyand EMS energy one of simultaneously or sequentially; transmittingfractionated energy from the source of fractionated energy through theprobe to tissue in the vicinity around the body orifice; and,transmitting EMS energy from the source of EMS energy through the probeto tissue in the vicinity around the body orifice.
 13. The method ofclaim 12, wherein the body orifice is selected from one of: a vaginalcavity; an anal cavity, the oral cavity or the aural cavity.
 14. Themethod of claim 13, wherein the treatment provides one of vaginal oranal tightening.
 15. The method of claim 12, wherein the fractionatedenergy is radio frequency (RF) energy.
 16. The method of claim 12,wherein the fractionated energy is Ultrasound (US) energy.
 17. Themethod of claim 12, wherein the fractionated energy is light energy. 18.The method of claim 12, further comprising the step of the controlleractivating the EMS energy first, followed by activation of the RFenergy, whereby the tissue in the vicinity of the body orifice is firstdrawn into contact with the probe, followed by activation of RF energy.19. The method of claim 18, wherein the controller activates theapplication of EMS energy and then RF energy a selected number of times.20. The method of claim 12, wherein the source of fractionated energyincludes electrodes mounted on an outer surface of the probe.
 21. Themethod of claim 20, wherein the electrodes are mounted in the form ofone or more spirals along the other surface of the probe.
 22. The methodof claim 12, wherein the method is practiced in one of office or homeuse.
 23. A method for providing fractional treatment of a body orificecomprising: transmitting fractionated energy from a source offractionated energy through a probe inserted in the body orifice totissue in the vicinity around the body orifice; and, transmitting EMSenergy from a source of EMS energy through the probe to tissue in thevicinity around the body orifice.
 24. The method of claim 23, furtherincluding the step of configuring a programmed controller to control thetransmitting of the one or more of fractionated and EMS energy one ofsimultaneously or sequentially.
 25. The method of claim 23, furthercomprising the step of the controller activating the EMS energy first,followed by activation of the RF energy, whereby the tissue in thevicinity of the body orifice is first drawn into contact with the probe,followed by activation of RF energy.
 26. The method of claim 25, whereinthe controller activates the application of EMS energy and then RFenergy a selected number of times.
 27. The method of claim 23, whereinthe method is practiced in one of an office or a home use.
 28. A devicefor providing fractional treatment of a body orifice comprising: asource of fractionated energy; a source of electrical muscle (EMS)energy; a programmed controller to control the application offractionated and/or EMS energy; a probe for insertion of its distal endinto the body orifice; the source of fractionated energy beingpositioned for transmitting fractionated energy from the source offractionated energy through the probe to tissue in the vicinity aroundthe body orifice; and, the source of EMS being positioned fortransmitting EMS energy from the source of EMS energy through the probeto tissue in the vicinity around the body orifice; and, wherein theprogrammed controller is configured to control the activation offractionated energy and/or the EMS energy.
 29. The device of claim 28,wherein the EMS energy is activated and the fractionated energy sourcenot activated for purposes of tightening the body orifice.